US2011039899A1PendingUtilityA1

Gabapentin for the Treatment of Overactive Bladder, Stress Incontinence and BPH

Assignee: PFIZERPriority: Dec 13, 2002Filed: Aug 28, 2008Published: Feb 17, 2011
Est. expiryDec 13, 2022(expired)· nominal 20-yr term from priority
A61K 31/198A61K 31/401A61K 31/16A61K 31/197A61K 31/662A61K 31/20A61K 31/4015A61K 31/41A61K 31/4245A61K 31/185A61K 31/433A61K 45/06A61K 31/18A61K 31/195A61P 13/00
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Claims

Abstract

Use of an alpha-2-delta ligand, or a pharmaceutically acceptable derivative thereof, for the manufacture of a medicament for the treatment of LUTS, other than urinary incontinence, associated with OAB and/or BPH.

Claims

exact text as granted — not AI-modified
1 . A method of treating LUTS, other than urinary incontinence, associated with OAB and/or BPH comprising administering an alpha-2-delta ligand, or a pharmaceutically acceptable salt or solvate thereof, to a patient in need of such treatment. 
     
     
         2 . The method of  claim 1 , wherein the LUTS is associated with BPH. 
     
     
         3 . The method of  claim 1 , wherein the LUTS is associated with OAB. 
     
     
         4 . The method of  claim 3 , wherein the OAB is OAB dry. 
     
     
         5 . The method of  claim 1 , wherein the LUTS is frequency. 
     
     
         6 . The method of  claim 1 , wherein the LUTS is nocturia. 
     
     
         7 . The method of  claim 1 , wherein the alpha-2-delta ligand is selected from the group consisting of: 
       
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt or solvate thereof;
 wherein R 1  and R 2  are each independently selected from H, straight or branched alkyl of 1-6 carbon atoms, cycloalkyl of from 3-6 carbon atoms, phenyl and benzyl, subject to the proviso that, except in the case of a tricyclooctane compound of formula (XVIII), R 1  and R 2  are not simultaneously hydrogen; or it is selected from the group consisting of: 
 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt or solvate thereof. 
     
     
         8 . The method of  claim 7  wherein the alpha-2-delta ligand is gabapentin (I) 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt or solvate thereof. 
     
     
         9 . The method of  claim 7  wherein the alpha-2-delta ligand is pregabalin (II) 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt or solvate thereof. 
     
     
         10 . The method of  claim 1  wherein the alpha-2-delta ligand is (1α,3α,5α)(3-amino-methyl-bicyclo[3.2.0]hept-3-yl)-acetic acid (III′) 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt or solvate thereof. 
     
     
         11 . The method of  claim 7 , wherein the alpha-2-delta ligand is 4-(3-fluoro-benzyl)-pyrrolidine-2-carboxylic acid (XXXV) 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt or solvate thereof. 
     
     
         12 . The method of  claim 7 , wherein the alpha-2-delta ligand is a compound of formula (XXX) as defined therein, or a pharmaceutically acceptable salt or solvate thereof. 
     
     
         13 . A method of treating LUTS associated with OAB and/or BPH comprising administering to a patient in need of such treatment a combination of an alpha-2-delta ligand and a compound selected from the group consisting of:
 (i) a PDEV inhibitory compound; and   (ii) a muscarinic antagonist;   
       or pharmaceutically acceptable salts or solvates thereof. 
     
     
         14 . The method of  claim 13 , wherein the alpha-2-delta ligand is administered in combination with a muscarinic antagonist. 
     
     
         15 . The method of  claim 14 , wherein the muscarinic antagonist is tolterodine. 
     
     
         16 . The method of  claim 13 , wherein the LUTS is other than urinary incontinence. 
     
     
         17 . The method of  claim 13 , wherein the LUTS is associated with BPH. 
     
     
         18 . The method of  claim 13 , wherein the LUTS is associated with OAB. 
     
     
         19 . The method of  claim 18 , wherein the OAB is OAB dry. 
     
     
         20 . The method of  claim 13 , wherein the LUTS is frequency. 
     
     
         21 . The method of  claim 13 , wherein the LUTS is nocturia. 
     
     
         22 . The method of  claim 13 , wherein the alpha-2-delta ligand is selected from the group consisting of: 
       
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt or solvate thereof;
 wherein R 1  and R 2  are each independently selected from H, straight or branched alkyl of 1-6 carbon atoms, cycloalkyl of from 3-6 carbon atoms, phenyl and benzyl, subject to the proviso that, except in the case of a tricyclooctane compound of formula (XVIII), R 1  and R 2  are not simultaneously hydrogen; or it is selected from the group consisting of: 
 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt or solvate thereof. 
     
     
         23 . The method of  claim 22  wherein the alpha-2-delta ligand is gabapentin (I) 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt or solvate thereof. 
     
     
         24 . The method of  claim 22  wherein the alpha-2-delta ligand is pregabalin (II) 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt or solvate thereof. 
     
     
         25 . The method of  claim 13  wherein the alpha-2-delta ligand is (1α,3α,5α)(3-amino-methyl-bicyclo[3.2.0]hept-3-yl)-acetic acid (III′) 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt or solvate thereof. 
     
     
         26 . The method of  claim 22 , wherein the alpha-2-delta ligand is 4-(3-fluoro-benzyl)-pyrrolidine-2-carboxylic acid (XXXV) 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt or solvate thereof. 
     
     
         27 . The method of  claim 22 , wherein the alpha-2-delta ligand is a compound of formula (XXX) as defined therein, or a pharmaceutically acceptable salt or solvate thereof. 
     
     
         28 . A pharmaceutical composition containing an alpha-2-delta ligand and a compound selected from the group consisting of:
 (i) a PDEV inhibitor; and   (ii) a muscarinic antagonist;   
       or a pharmaceutically acceptable salt or solvate thereof and a pharmaceutically acceptable carrier. 
     
     
         29 . The pharmaceutical composition of  claim 28 , wherein the alpha-2-delta ligand is selected from the group consisting of: 
       
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt or solvate thereof;
 wherein R 1  and R 2  are each independently selected from H, straight or branched alkyl of 1-6 carbon atoms, cycloalkyl of from 3-6 carbon atoms, phenyl and benzyl, subject to the proviso that, except in the case of a tricyclooctane compound of formula (XVIII), R 1  and R 2  are not simultaneously hydrogen; or it is selected from the group consisting of: 
 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt or solvate thereof, and is in combination with a muscarinic antagonist. 
     
     
         30 . The pharmaceutical composition of  claim 29 , wherein the muscarinic antagonist is tolterodine.

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